On August 3, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the second quarter ended June 30, 2021 (Press release, Neurocrine Biosciences, AUG 3, 2021, View Source [SID1234585604]).
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"We helped more tardive dyskinesia patients than ever before as our second quarter results reflect sustained growth for INGREZZA. While 8 out of 10 patients still remain undiagnosed, the underlying opportunity to improve the lives of patients with TD remains strong. Therefore, we continue to invest in healthcare provider and patient-focused awareness campaigns to help improve TD diagnosis and treatment rates," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We remain committed to advancing our R&D pipeline and are making steady progress towards initiating 9 mid-to-late-stage clinical trials this year. With significant long-term commercial growth opportunities and a diverse and growing pipeline, we are well positioned to become a leading neuroscience-focused biopharmaceutical company."
Second Quarter Net Product Sales and Commercial Highlights:
INGREZZA net product sales for the second quarter of 2021 were $265 million and $269 million on an inventory adjusted basis
Record total prescriptions achieved during the second quarter 2021 reflecting increased commercial activities
New prescriptions increased throughout the second quarter, reaching their highest levels since March 2020 despite continued significant use of telemedicine within psychiatry
Second quarter refill rates per patient returned to historical normal range versus seasonally low first quarter levels
Financial Highlights:
Second quarter 2021 GAAP net income and diluted earnings per share were approximately $42 million and $0.43, respectively, compared with approximately $80 million and $0.81, respectively, in the second quarter of 2020
Second quarter 2021 non-GAAP net income and diluted earnings per share were approximately $61 million and $0.63, respectively, compared with approximately $139 million and $1.42, respectively, in the second quarter of 2020
Difference between second quarter 2021 GAAP and non-GAAP net income and diluted earnings per share compared with the second quarter of 2020 were driven by:
Increased research and development expense primarily due to increased investment and headcount to support our expanded pipeline programs
Increased selling, general and administrative expense primarily due to increased investment in commercial initiatives including the launch of "TD Spotlight", our INGREZZA direct-to-consumer advertising campaign
Second quarter 2021 provision for income taxes was $15 million, compared with $4 million in the second quarter of 2020. In the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to the Company’s ability to offset its pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021.
At June 30, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of $1.2 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.
Recent Events
In April 2021, Mitsubishi Tanabe Pharma Corporation (MTPC) submitted a Marketing Authorization Application, or MAA, with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. The MTPC submission of valbenazine triggered a milestone payment of $15 million, which the Company recognized as collaboration revenue in the second quarter of 2021.
In August 2021, the Company announced plans to initiate registrational studies in the second half of 2021 with valbenazine for adjunctive treatment in schizophrenia and for dyskinesia due to cerebral palsy.
GAAP-only guidance includes approximately $130 million of share-based compensation and $5 million of In-Process Research and Development (IPR&D). GAAP-only guidance does not include any potential milestones or IPR&D costs associated with current collaborations or future business development activities.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.